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NCT01666652 · ClinicalTrials.gov registry record · Phase 1
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT01666652: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT01666652 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01666652, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.
Primary Outcome
Number of subjects with adverse events occurring within days 0-28 following vaccination
Interventions
- OTHER Phosphate buffered saline
- BIOLOGICAL 4 µg TDENV-PIV with Alum adjuvant
- BIOLOGICAL 1 µg TDENV-PIV with AS03B1 adjuvant
- BIOLOGICAL 1 µg TDENV-PIV with Alum adjuvant
- BIOLOGICAL 1 µg TDENV-PIV with AS01E1 adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-11 |
| Phase | Phase 1 |
What the finished NCT01666652 record still lists
NCT01666652 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 5 interventions - of which Phosphate buffered saline is the first listed.
NCT01666652 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01666652 about?
NCT01666652 is a clinical study titled "A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults". The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.
What is the current status of trial NCT01666652?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2012-09. Estimated completion is 2017-11.
What interventions are being tested in trial NCT01666652?
The interventions under investigation include: Phosphate buffered saline (OTHER), 4 µg TDENV-PIV with Alum adjuvant (BIOLOGICAL), 1 µg TDENV-PIV with AS03B1 adjuvant (BIOLOGICAL), 1 µg TDENV-PIV with Alum adjuvant (BIOLOGICAL), 1 µg TDENV-PIV with AS01E1 adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01666652?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01666652's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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